능동 이식형 의료기기(AIMD) 시장 : 예측(2021-2026년)

Active Implantable Medical Devices (AIMD) Market - Forecasts from 2021 to 2026

발행일: | 리서치사: Knowledge Sourcing Intelligence | 페이지 정보: 영문 114 Pages | 배송안내 : 1-2일 (영업일 기준)

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세계의 능동 이식형 의료기기 시장 규모는 2019년 238억 1,800만 달러에서 2026년에는 368억 4,500만 달러에 달하고, 예측 기간 중 6.43%의 연평균 복합 성장률(CAGR)을 나타낼 것으로 예상됩니다.

시장 성장은 세계적으로 심혈관질환이나 신경질환이 증가하고 있는 점에 기인한 것으로 생각할 수 있습니다. 또한 첨단 제품을 개발하기 위한 기업의 투자나 자금이 증가하고 있는 점 또한 예측기간 중 시장 성장을 가속하는 요인입니다. 그러나, 능동 이식형 의료기기에 관한 엄격한 규제 정책과 기기의 높은 가격이 일정기간 시장 성장을 억제할 가능성이 있습니다. 최근 몇 년간 대기업이 이 시장에서 큰 발전을 이루었습니다. 기술 혁신, 연구개발, 인프라 투자가 증가하고 있기 때문에 향후 몇 년간 시장은 급속하게 확대될 것으로 예상됩니다.

The Active Implantable Medical Device(AIMD)의 지침에 따르면 능동 이식형 의료기기란 '외과적 또는 의학적으로 인체에나 의료 개입에 의해 자연스러운 구멍에 전체적 또는 부분적으로 도입하는 것을 의도하고, 시술 후 잔존을 의도하고 있는 모든 능동적인 의료기기'로 여겨집니다. 이식형 페이스메이커, 인공와우, 보조인공심장, 신경 자극 기기 등이 능동 이식형 의료기기의 일례입니다. 능동 이식형 의료기기는 미국 식품의약국(FDA)이 리스트업하고 있는 의료기기 중에서 가장 리스크가 높은 카테고리로 분류됩니다.

능동 이식형 의료기기(AIMD: Active Implantable Medical Devices) 시장을 조사했으며, 시장 개요, 시장 성장 촉진요인 및 억제요인, 제품별·최종사용자별·지역별 분석, 주요 기업의 상황과 경쟁 구도 등의 정보를 제공합니다.


제1장 서론

  • 시장의 정의
  • 시장 세분화

제2장 조사 방법

  • 조사 데이터
  • 전제조건

제3장 개요

  • 조사 하이라이트

제4장 시장 역학

  • 성장 촉진요인
  • 성장 억제요인
  • Porter의 산업 분석
    • 공급 기업의 거래
    • 구입 기업의 거래
    • 신규 진출업체의 위협
    • 대체품의 위협
    • 업계 경쟁 기업간 경쟁 관계
  • 업계 밸류체인 분석

제5장 제품별 : 능동 이식형 의료기기 시장 분석

  • 서론
  • 보조인공심장
  • 신경 자극 기기
  • 이식형 심장 페이스메이커
  • 인공와우
  • 기타

제6장 최종사용자별 : 능동 이식형 의료기기 시장 분석

  • 서론
  • 병원/클리닉
  • 외래수술센터

제7장 지역별 : 능동 이식형 의료기기 시장 분석

  • 서론
  • 북미
    • 미국
    • 캐나다
    • 멕시코
  • 남미
    • 브라질
    • 아르헨티나
    • 기타
  • 유럽
    • 영국
    • 프랑스
    • 독일
    • 이탈리아
    • 기타
  • 중동 및 아프리카
  • 아시아태평양
    • 일본
    • 중국
    • 인도
    • 태국
    • 대만
    • 인도네시아
    • 기타

제8장 경쟁 환경과 분석

  • 주요 기업과 전략 분석
  • 신규 기업과 시장 수익성
  • 합병/인수/합의/협업
  • 벤더 경쟁력 매트릭스

제9장 기업 개요

  • Sonova Holding AG
  • Medtronic
  • Abbott
  • Lifetech Scientific
  • Boston Scientific Corporation
  • Cochlear Ltd.
  • MED-EL
  • LivaNova PLC
  • Advanced Bionics AG
LSH 21.09.09

The global active implantable medical devices market is expected to grow at a CAGR of 6.43% over the forecast period to reach a market size of US$36.845 billion in 2026 from US$23.818 billion in 2019. As per The Active Implantable Medical Device (AIMD) Directive, an active implantable medical device is "any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure". An implantable pacemaker, cochlear implants, ventricular assist devices, neurostimulators are some of the active implantable medical devices. Active implantable medical devices fall into the highest risk categories of medical devices listing by the U.S. Food & Drug Administration (FDA). The growth in the market may be attributed to the rising prevalence of cardiovascular and neurological disorders across the globe. Rising investments and funds by the companies to develop technologically advanced products will also boost the market for AIMD during the given forecast period. However, strict regulatory policies regarding the AIMD and the high cost of the devices may restrain the market growth during the given time frame. Major companies have been making significant developments in the market, in the past few years. With the increasing investment in innovation, research and development, and infrastructure, the market is expected to surge at an exponential rate in the coming years.

Increasing cardiovascular diseases.

The market is expected to surge in the coming years, due to the rising prevalence of cardiovascular diseases, globally. Cardiovascular diseases are one of the leading causes of death, worldwide. According to the data given by the World Health Organisation, an estimated number of 17.9 million people had died from cardiovascular diseases in the year 2019. Around 85% of these deaths were attributed to stroke and heart attack. An estimated 1.13 billion people, globally, have been suffering from hypertension, which has become a major cause of brain, heart, kidney, and other related problems. Some of the devices, such as implantable cardioverter-defibrillator have been expected to show a significant surge in the demand, in the coming period. It is a device that is usually placed on the chest, to detect irregular heartbeats and monitor heart rhythm. Major companies have been making significant developments in the market. For instance, Medtronic, one of the major players in the market, provides implantable cardioverter defibrillators to their customers. The company's model and devices, known as Cobalt XT IDDs, are enabled with advanced BlueSync technology, which allows for app-based monitoring and tablet-based monitoring. These developments are expected to enhance the overall market growth, in the coming years.

Increasing government regulations.

The European Union had announced that it had published an updated list of regulations and standards, that would be used to showcase and demonstrate conformity with required and essential requirements of its major flagship derivate known Directive 90/385/EEC, which are related to active implantable devices. According to the directive given by the European Union, an active medical device would be a major functioning source of electrical energy or any other source of energy, but different than directly released by the gravity or human body. Moreover, increasing regulations in North America, Asia Pacific, and other regions are also expected to provide a challenge to the overall market growth.

Latest Developments.

Major companies, research institutions, and organizations have been making considerable investments, intending to develop novel, advanced, and innovative active implantable medical devices for their customers.

  • In May 2021, Researchers at the Columbia University announced that they had developed a novel single-chip device that takes less than 0.1 mm3. It had been one of the smallest systems, ever developed and designed. The researchers stated that the device would be injected into humans, to monitor certain biological parameters. The major goal of this research has been to replace larger implantable sensors, that require several packaging, chips, batteries, external transducers, and wires. This development is expected to have a positive impact on the market, in the coming years.
  • In June 2021, FineHeart S.A., a preclinical medical device firm, announced that they had completed a EUR15 million funding round. The company had been developed an implantable cardiac output management system, called FLOWMAKER, to address the need of patients, that are suffering from severe heart failure. The company has also stated that the novel funding would allow preparing for first in human clinical trials in the year 2022.

North America is expected to have a major share.

North American region is expected to have a major share in the market, due to the rise in the number of active implantable medical device start-ups, the presence of some of the major players in the region, and increased cardiovascular problems. Other regions are also expected to exhibit higher potential in the overall market. With the rise in the geriatric population and surging cardiovascular concerns, Europe is expected to register significant CAGR growth, during the forecast period. Countries like Germany and Italy are expected to emerge as a major potential region, in the coming years.

Market Segmentation:

  • By Type
  • Ventricular Assist Devices
  • Neurostimulators
  • Implantable Cardiac Pacemakers
  • Cochlear Implants
  • Others
  • By End-User
  • Hospitals & Clinics
  • Ambulatory Surgical Centers
  • By Geography
  • North America
  • USA
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • UK
  • Germany
  • France
  • Italy
  • Others
  • Middle East and Africa
  • Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Thailand
  • Taiwan
  • Indonesia
  • Others

Table of Contents

1. Introduction

  • 1.1. Market Definition
  • 1.2. Market Segmentation

2. Research Methodology

  • 2.1. Research Data
  • 2.2. Assumptions

3. Executive Summary

  • 3.1. Research Highlights

4. Market Dynamics

  • 4.1. Market Drivers
  • 4.2. Market Restraints
  • 4.3. Porters Five Forces Analysis
    • 4.3.1. Bargaining Power of Suppliers
    • 4.3.2. Bargaining Power of Buyers
    • 4.3.3. The Threat of New Entrants
    • 4.3.4. Threat of Substitutes
    • 4.3.5. Competitive Rivalry in the Industry
  • 4.4. Industry Value Chain Analysis

5. Active Implantable Medical Devices Market Analysis, By Product

  • 5.1. Introduction
  • 5.2. Ventricular Assist Devices
  • 5.3. Neurostimulators
  • 5.4. Implantable Cardiac Pacemakers
  • 5.5. Cochlear Implants
  • 5.6. Others

6. Active Implantable Medical Devices Market Analysis, By End-User

  • 6.1. Introduction
  • 6.2. Hospitals & Clinics
  • 6.3. Ambulatory Surgical Centers

7. Active Implantable Medical Devices Market Analysis, By Geography

  • 7.1. Introduction
  • 7.2. North America
    • 7.2.1. United States
    • 7.2.2. Canada
    • 7.2.3. Mexico
  • 7.3. South America
    • 7.3.1. Brazil
    • 7.3.2. Argentina
    • 7.3.3. Others
  • 7.4. Europe
    • 7.4.1. UK
    • 7.4.2. France
    • 7.4.3. Germany
    • 7.4.4. Italy
    • 7.4.5. Others
  • 7.5. The Middle East and Africa
  • 7.6. Asia Pacific
    • 7.6.1. Japan
    • 7.6.2. China
    • 7.6.3. India
    • 7.6.4. Thailand
    • 7.6.5. Taiwan
    • 7.6.6. Indonesia
    • 7.6.7. Others

8. Competitive Environment and Analysis

  • 8.1. Major Players and Strategy Analysis
  • 8.2. Emerging Players and Market Lucrativeness
  • 8.3. Mergers, Acquisitions, Agreements, and Collaborations
  • 8.4. Vendor Competitiveness Matrix

9. Company Profiles

  • 9.1. Sonova Holding AG
  • 9.2. Medtronic
  • 9.3. Abbott
  • 9.4. Lifetech Scientific
  • 9.5. Boston Scientific Corporation
  • 9.6. Cochlear Ltd.
  • 9.7. MED-EL
  • 9.8. BIOTRONIK SE & CO. KG
  • 9.9. LivaNova PLC
  • 9.10. Advanced Bionics AG
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